1. Field of the Invention
This invention relates to packages for surgical sutures and needles. Conventional surgical suture and needle packages serve several useful functions, including protecting the needles and sutures during handling, shipping, and storage. In addition, the packages facilitate access and release of the needles and sutures during surgery or other medical procedures prior to application with a minimum of force to dispense. The packages may be used for surgical sutures armed with surgical needles or for unarmed surgical sutures without needles.
2. Description of the Related Art
Packaging for surgical sutures with or without needles is well known in the art. There are two types of packages that have been conventionally used for surgical needles and sutures. One type of package is a paper folder package wherein a medical grade paperboard is folded and cut into a plurality of panels. The suture is then wound onto a panel, and the package is then assembled by first folding the panels into a desired configuration, and then locking the panels in place using slits and locking tabs which have been cut into the panels.
Another type of suture package which has been used is a tray package having a winding channel. These tray packages typically have an oval shape with outer and inner walls forming an oval winding channel. The packages are typically moulded from plastics. The packages are mounted onto a winding fixture and sutures are then wound into the winding channel. Suture packages typically have a needle park member for mounting and securing a surgical needle if a surgical needle is mounted to the sutures. Conventional needle parks can consist of foam members, or equivalent retention structures. The needle park members can also be utilized for mounting one end of a suture wound into the winding channel.
U.S. Pat. No. 4,961,498 discloses a two-piece suture package having an oval winding channel. U.S. Pat. No. 4,967,902 discloses a one-piece channel suture package having a plurality of door members which retain the suture in the channel. U.S. Pat. No. 5,230,424 discloses a package having a substantially square shape and having a square shaped suture channel wherein a plurality of cantilevered doors are mounted to an inner wall to maintain sutures in the channel. U.S. Pat. No. 5,655,652 discloses a package having an oval-shaped winding channel with a top friction plate member in lieu of doors or cantilevered doors.
U.S. Pat. No. 6,135,272 discloses a plurality of cantilevered cover door or petal members with spaces in between. These door members have a disadvantage of deforming if the stylus is moving at a high speed therefore limiting the winding speed. They also have a disadvantage of allowing the smaller diameter suture to escape through the spaces in between these door members.
WO 2013/049400 A1 discloses a suture package having two halves. The interior of the body portion is provided with a pair of posts in one half of the body portion and a corresponding pair of mating bosses in the other half of the body portion. When the two halves of the base are pressed together, the posts fit into the bosses in a press fit or snap fit manner to secure the two halves together. The posts and bosses also provide a structure around which the suture strands may be wrapped.
EP 2 172 157 A1 discloses a suture package for retaining a barbed suture including a suture retaining member with an outer wall and an inner wall. The inner wall is radially spaced from the outer wall and defines a suture retaining area therebetween. The outer wall includes a plurality of inwardly extending tabs configured to engage a cover. The suture package further includes a cover configured to be received within the outer wall of the suture retaining member and to selectively engage the inwardly extending tabs formed thereon.
EP 3 095 392 A1 discloses a package for sutures having a winding channel created by having an outside wall and an inner row of cylindrical standoff members to form a channel for sutures. The package has a base member and a flat cover ember that is mounted to the base member by a plurality of snap locks located on top of the cylindrical standoff members. The edge of the base member has cover locking tabs along the outside wall.
Although the suture tray packages of the prior art are adequate and effective for their intended use, there are disadvantages associated with such packages. An example of one type of problem which may occur is suture “hang-up” when the surgeon attempts to withdraw the suture from the package or when the suture is very hard to withdraw or has a high dispense force. Accordingly, there is a need in this art for novel suture tray packages having winding channels which are readily adaptable to high-speed packaging processes running at over 1200 rpm which overcome the disadvantages of the prior art packages, including problems associated with suture withdrawal. Accordingly, there is a need in this art for novel suture tray packages having a larger suture track volume for the larger sized sutures. Furthermore, there is a need in this art for novel suture tray packages having the capability to contain the micro sutures such as USP 10-0 in the suture channel.